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23andMe Launches First Direct-to-Consumer Genetic Service with Tests that Meet FDA Standards

Twitter Summary: @23andMe launches first genetic service available directly to consumers with reports that meet @US_FDA standards; $199 for new product

The personal genetics company 23andMe recently announced the launch of its new “Personal Genome Service,” which is the first and only direct-to-consumer genetic service that includes reports that meet FDA standards for being scientifically and clinically valid. What a victory! 23andMe can now provide consumers with some limited health information based on their DNA (taken through a saliva sample mailed to a CLIA-certified lab). It costs $199 and can be ordered online here. Customers who purchased 23andMe prior to launch of the new service will be transitioned to the new service as quickly as possible (dependent on validation and local requirements). For more information on this transition, please visit their new FAQ page here.

The service includes “carrier status tests” that inform people whether they carry a single genetic variant for 36 inherited conditions that are passed down genetically. This can indicate the risk for offspring to inherit a particular health condition like cystic fibrosis, sickle cell anemia, and Tay-Sachs disease. 23andMe told us they will continue to seek additional FDA clearance for new reports. 

This new release comes almost two years after the FDA banned 23andMe in November 2013 from offering direct-to-consumer genetic health reports. Citing uncertainty over whether the test was safe and accurate for patients, the FDA restricted 23andMe to only offer genetic information regarding ancestry, as well as raw, un-interpreted genetic information. Ancestry reports and tools include tracing genetic lineage to populations around the world, such as Eastern European, Native American, etc., and finding DNA relatives who have also tested with 23andMe and opted in to the company’s DNA relatives feature.

This new service offers more insight than the ancestry-only version, but it is still limited in scope compared to the pre-November 2013 product. Renowned endocrinologist and 23andMe user Dr. Anne Peters believes this new test is a “great start” for getting people safe access to their genetic information in a direct-to-consumer (DTC) fashion.

While 23andMe is the first DTC health-related genetic service with tests that meet FDA standards, there are several companies that will sequence and analyze individuals’ DNA with the help of healthcare providers – CounsylPathway Genomics, and Myriad Genetics are examples of companies that perform clinical analyses of patients’ DNA (through a health care professional, not DTC). If you are interested in having your genome sequenced and interpreted by a geneticist, we recommend talking to your healthcare provider first. 

[Photo Credit: 23andMe]